Statin-associated MyalgiaPhase 4NCT00590408
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
A Phase 4 study testing coenzyme Q10 in people with Statin-associated Myalgia, run by Creighton University at 1 site in United States.
Trial summary
Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Statin-associated Myalgia
- What is being tested?
- coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level
Who cannot join
- Women of childbearing potential
- Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
- Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins
- Patients with a history of alcoholism or malnutrition
- Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
- Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cardiac Center of Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.
- Conditions
- Statin-associated Myalgia
- Being tested
- coenzyme Q10, matching placebo
- Keywords
- coenzyme Q10, statin, myalgia
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coenzyme Q10Dietary supplement
60mg capsule twice daily for 12 weeks
matching placeboDietary supplement
matching placebo capsule twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Dietary Supplement: coenzyme Q10 |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Measured: every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks
Secondary outcomes (1)
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Measured: every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin-associated MyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Investigators
- Robyn Kondrack, PharmD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590408
- Sponsor's protocol ID
- 05-13642
- Other IDs
- 05-13642
- Status last verified
- Nov 2009
- First submitted
- 28 Dec 2007
- Last updated
- 1 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
- ClinicalTrials.gov ID
- NCT00590408
- Acronym / sponsor ID
- 05-13642
- Conditions
- Statin-associated Myalgia
- Keywords
- coenzyme Q10, statin, myalgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: coenzyme Q10 |
| 2 | Placebo comparator | Dietary Supplement: matching placebo |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level
Key exclusion criteria (6 listed)
- Women of childbearing potential
- Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
- Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins
- Patients with a history of alcoholism or malnutrition
- Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coenzyme Q1060mg capsule twice daily for 12 weeks | Dietary supplement | 1 |
| matching placebomatching placebo capsule twice daily for 12 weeks | Dietary supplement | 2 |
Primary outcome
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time frame: every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks
1 secondary outcome
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time frame: every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Kondrack, PharmD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing coenzyme Q10 in people with Statin-associated Myalgia, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy (time frame: every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2009.